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The Microbial CMO: Process Development and Manufacturing of Biologics August 2016

Ilona Koebsch

August 10, 2016

3 Min Read

Logo_Wacker-300x80.jpgWacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP production of biologics for clinical trials and commercial supply. Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we are a 100% subsidiary of Wacker Chemie AG since 2005.

The sites in Jena and Halle provide a complete range of services for the development and GMP-compliant manufacture of biopharmaceuticals. Two manufacturing lines with 300-L and 1,500-L fermentation vessels and matching DSP scales are available to suit all possible customers’ needs.

WACKER holds biomanufacturing certificates from the relevant authorities for both sites and follows the ICH Q7A guidelines for GMP-compliant production of biologics. Since 2012, the facility in Halle has been EMA-approved/FDA-inspected for the commercial production of Reteplase (trade names Rapilysin® and Retavase®), a thrombolytic drug that is indicated to treat acute myocardial infarction. Very recently, the Jena plant received EMA approval for manufacturing of the approved product Spectrila®, a recombinant l-asparaginase for treatment of childhood leukemia.

WACKER rounds out its offering with outstanding Escherichia coli technologies that can significantly increase the bioprocess efficiency and thus reduce cost of goods.

12-7-Wacker-photo-300x200.jpgServices Portfolio
Project Management: We work in close collaboration with our customers. Projects are managed by dedicated project managers supported by cross-departmental teams. Depending on our customers’ requirements, we have the flexibility to perform the whole process development or to transfer projects at various stages.

Cell Line Engineering

  • Construction and optimization of host/vector systems (E. coli, yeast)

  • Production and characterization of master and working cell banks.

Process Development and GMP Manufacturing

  • Efficient process development and optimization

  • Process transfer

  • Process scale from 20 L to 1,500 L

  • GMP-compliant production

  • Process validation.

Quality control

  • Development of analytical methods

  • Assay qualification and validation

  • Release testing

  • ICH-compliant stability testing.

Quality assurance

  • Ensured regulatory compliance in all aspects of manufacturing and quality control

  • Batch release by qualified person

  • Support with dossiers (e.g., IND or IMPD).

Cost-Saving Technologies
ESETEC® and ESETEC® 2.0 — E. coli Secretion Technology: WACKER’s secretion system allows for high yields of correctly folded proteins in a culture broth. It consists of an engineered E. coli K12-based host strain, a set of proprietary plasmids, and a genetic toolbox to increase secretion. The technology has been successfully used to produce a broad variety of recombinant proteins, including therapeutic Fabs and scaffolds.

FOLDTEC®: Using rational experimental design with a proprietary expression vector portfolio, WACKER provides solutions for complex and challenging in vitro folding processes. Better folding efficiencies and smaller folding volumes render fully scalable manufacturing processes with superior productivity.

PASylation® — Innovative Technology for Extension of Plasma Half-Life: In collaboration with the German company XL-protein GmbH, WACKER offers the production of PASylated biopharmaceuticals using ESETEC®. Recently, PASylated Fabs were produced with yields >4 g/L.

Dr. Ilona Koebsch is business development manager, Hans-Knöll-Str. 3, 07745 Jena, Germany; 49-3641-53-48-150; fax 49-3641-53-48-160; [email protected]; www.wacker.com/biologics.

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